Cleared Traditional

K811587 - SIEMENS ANGIOTRON (FDA 510(k) Clearance)

Class I Radiology device.

K811587 · Siemens Corp. · Radiology device
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Jul 1981
Decision
35d
Days
Class 1
Risk

K811587 is an FDA 510(k) clearance for the SIEMENS ANGIOTRON. Classified as Synchronizer, Ecg / Respirator, Radiographic (product code IXO), Class I - General Controls.

Submitted by Siemens Corp. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1970 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Corp. devices

Submission Details

510(k) Number K811587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1981
Decision Date July 10, 1981
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXO Synchronizer, Ecg / Respirator, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1970
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.